Ondalenz 8 mg 5 oral films

Ondalenz 8 mg 5 oral films

Composition:
Active ingredient:
Ondansetron (micronized) - 8 mg per film.
Excipients:
Polyvinyl alcohol, Polyethylene glycol 1000, Rice starch, Glycerol, Hydroxypropyl methylcellulose E3, Sucralose, Polyethylene glycol 400, Menthol pellets, Strawberry flavour, Simethicone 30% suspension, Carmoisine color 20% (CI 14720).
Description:
Oral soluble films designed for rapid dissolution on the tongue without the need for water.
Indicated for prevention and treatment of nausea and vomiting associated with chemotherapy, radiotherapy and surgical procedures.
Indications:
Adults:
- Prevention of acute nausea and vomiting induced by moderately emetogenic chemotherapy.
- Prevention and treatment of delayed nausea/vomiting from moderate to highly emetogenic chemotherapy or radiotherapy.
- Prevention and treatment of post-operative nausea and vomiting (PONV).
Paediatric population:
- Management of chemotherapy-induced nausea and vomiting in children ≥ 6 months.
- Prevention and treatment of PONV in children ≥ 4 years.
Dosage and Method of Administration:
For oral use only.
Place film on the tongue; it dissolves rapidly.
Do not handle with wet fingers.
- Chemotherapy/Radiotherapy:
(Adults)
Moderately emetogenic therapy:
- 8 mg orally 1-2 hours before treatment
- 8 mg 12 hours later
To prevent delayed emesis:
8 mg twice daily for up to 5 days.
Highly emetogenic chemotherapy:
- 24 mg + oral dexamethasone 12 mg 1-2 hours before treatment
- Then 8 mg twice daily for up to 5 days.
- Post-operative nausea and vomiting
(Adults)
Prevention:
- 16 mg 1 hour before anaesthesia or - 8 mg 1 hour before anaesthesia + 8 mg every 8 hours (two doses).
Contraindications:
- Hypersensitivity to ondansetron or other 5-HT₃ antagonists.
- Concomitant use with apomorphine (risk of profound hypotension and loss of consciousness).
- Congenital long QT syndrome.
Precautions:
- Hypersensitivity reactions may occur.
- Ondansetron prolongs QT interval. 
Use cautiously in:
- Heart failure, bradyarrhythmia, - electrolyte disorders, - patients taking QT-prolonging drugs.
- Correct hypokalemia and hypomagnesemia before administration.
- Serotonin syndrome reported with SSRIs/SNRIs.
- Monitor patients at risk for intestinal obstruction.
- May mask bleeding after adeno-tonsillar surgery.
- Monitor liver function when used with hepatotoxic chemotherapy in children.
- Use caution in hepatic impairment (prolonged elimination).
- Not recommended in children <2 years for PONV.
Side Effects :
Very common:
- Headache
Common:
- Constipation
- Feeling of warmth/flushing
- Asymptomatic elevation of liver enzymes
Uncommon:
- Seizures
- Extrapyramidal reactions
- Arrhythmias, bradycardia 
- Hypotension
- Hiccups
Rare:
- Transient visual disturbances
- Immediate allergic reactions (incl. anaphylaxis).
Pregnancy and Breastfeeding:
Pregnancy:
- Should not be used during the first trimester (associated with increased risk of orofacial clefts).
- Use only if benefit outweighs risk afterwards.
Breastfeeding:
- Excreted into breast milk
- Breastfeeding is not recommended during therapy.
Storage Conditions:
Store below 30°C.
Keep in original packaging.
Keep out of reach of children.
Packaging:
Carton box with 5 individually sealed child-resistant pouches and leaflet.